ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
DUKORAL suspension and effervescent granules for oral suspension
Cholera vaccine (inactivated, oral)
2.
Each dose of vaccine suspension (3 ml) contains:
A total of 1x10
11
bacteria of the following strains:
Vibrio cholerae
O1 Inaba, classical biotype
(heat inactivated) 25x10
9
bacteria*
Vibrio cholerae
O1 Inaba, El Tor biotype (formalin inactivated) 25x10
9
bacteria*
Vibrio cholerae
O1 Ogawa, classical biotype (heat inactivated) 25x10
9
bacteria*
Vibrio cholerae
O1 Ogawa, classical biotype (formalin inactivated) 25x10
9
bacteria*
Recombinant cholera toxin B subunit (rCTB) 1 mg
(produced in
V. cholerae
O1 Inaba, classical biotype strain 213.)
* Bacterial count before inactivation.
Excipients:
Sodium dihydrogen phosphate monohydrate 1.7 mg, disodium hydrogen phosphate dihydrate 9.4 mg,
sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg,
saccharin sodium 30 mg, sodium citrate 6 mg.
One dose contains approximately 1.1 g sodium.
For a full list of excipients, see section 6.1.
3.
Suspension and effervescent granules for oral suspension.
The suspension, supplied in a vial is whitish. The effervescent granules, supplied in a sachet, are
white.
4.
DUKORAL is indicated for active immunisation against disease caused by
Vibrio cholerae
serogroup
O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.
The use of DUKORAL should be determined on the basis of official recommendations taking into
consideration the variability of epidemiology and the risk of contracting disease in different
geographical areas and travelling conditions.
DUKORAL should not replace standard protective measures. In the event of diarrhoea measures of
rehydration should be instituted.
Primary vaccination schedule
2
The standard primary course of vaccination with DUKORAL against cholera consists of 2 doses for
adults and children from 6 years of age. Children 2 to 6 years of age should receive 3 doses. Doses are
to be administered at intervals of at least one week. If more than 6 weeks have elapsed between doses,
the primary immunisation course should be re-started.
Immunisation should be completed at least 1 week prior to potential exposure to
V. cholerae
O1.
Booster dose
For continuous protection against cholera a single booster dose is recommended within 2 years for
adults and children from 6 years of age, and after 6 months for children aged 2 to 6 years. No clinical
efficacy data has been generated on repeat booster dosing. However, immunological data suggest that
if up to 2 years have elapsed since the last vaccination a single booster dose should be given. If more
than 2 years have elapsed since the last vaccination the primary course should be repeated.
Children less than 2 years
DUKORAL has been given to children between 1 and 2 years of age in safety and immunogenicity
studies, but the protective efficacy has not been studied in this age group. Therefore, DUKORAL is
not recommended to be used in children less than 2 years of age.
Elderly
There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and
more.
Method of administration
The vaccine is intended for oral use. Before ingestion, the vaccine suspension should be mixed with a
sodium hydrogen carbonate solution. The sodium hydrogen carbonate is supplied as effervescent
granules, which should be dissolved in a glass of cool water (approx. 150 ml). The vaccine suspension
should then be mixed with the sodium hydrogen carbonate solution and drunk within 2 hours. Food
and drink should be avoided 1 hour before and 1 hour after vaccination. Oral administration of other
medicinal products should be avoided within 1 hour before and after administration of DUKORAL.
Children 2 to 6 years of age:
half of the sodium hydrogen carbonate solution is poured away and the
remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Hypersensitivity to the active substances, to any of the excipients or to formaldehyde.
Administration of DUKORAL should be postponed for subjects suffering from acute gastrointestinal
illness or acute febrile illness.
No clinical data on protective efficacy of DUKORAL against cholera after administration of booster
doses are available.
DUKORAL confers protection specific to
Vibrio cholerae
serogroup O1. Immunisation does not
protect against
V. cholerae
serogroup O139 or other species of Vibrio.
In subjects infected with HIV, limited data are available on immunogenicity and safety of the vaccine.
Vaccine protective efficacy has not been studied. Immunisation of HIV infected subjects could result
in transient increases of viral load. DUKORAL may not induce protective antibody levels in subjects
with advanced HIV disease. However, an effectiveness study in a population with high HIV
prevalence showed similar protection as in other populations.
3
Antibody response in vaccinees with endogenous or iatrogenic immunosuppression may be
insufficient.
Formaldehyde is used during the manufacturing process and trace amounts may be present in the final
product. Caution should be taken in subjects with known hypersensitivity to formaldehyde.
DUKORAL contains approximately 1.1 g sodium per dose, which should be taken into consideration
by patients on a controlled sodium diet.
The vaccine does not provide complete protection and it is important to adhere to standard protective
measures to avoid cholera.
The vaccine is acid labile. Food and/or drink will increase acid production in the stomach and the
effect of the vaccine may be impaired. Consequently, food and drink should be avoided 1 hour before
and 1 hour after vaccination.
Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1
hour after vaccination.
Preliminary results from a clinical study including a limited number of volunteers showed no
interaction with the antibody response to DUKORAL when a live oral vaccine (enterocapsules)
against typhoid was given simultaneously with DUKORAL. The immune response to live typhoid
vaccine was not investigated in this study. Similarly, a yellow fever vaccine was given concomitantly
with DUKORAL, and there was no interaction observed with the immune response to the yellow fever
vaccine. The immune responses to DUKORAL were not studied. No other vaccines/ medicinal
products, including oral polio vaccine and antimalarials, have been given simultaneously with
DUKORAL in clinical studies.
No animal data on reproduction toxicity are available. Following careful benefit/risk assessment the
vaccine may be administered during pregnancy and to breast-feeding women although no specific
clinical studies have been performed to address this issue.
There is no evidence of an effect on the ability to drive and use machines.
The safety of DUKORAL was assessed in clinical trials, including both adults and children from 2
years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic
Escherichia coli
(ETEC) producing heat-labile enterotoxin (LT). Over 94,000 doses of DUKORAL
were administered during the clinical trials. Evaluation of safety varied between trials with respect to
mode of surveillance, definition of symptoms and time of follow-up. In the majority of studies adverse
events were assessed by passive surveillance. The most frequently reported adverse reactions, such as
gastrointestinal symptoms including abdominal pain, diarrhoea, loose stools, nausea and vomiting,
occurred at similar frequencies in vaccine and placebo groups.
Frequency classification: Very common (
≥
1/10); common (
≥
1/100 to <1/10); uncommon
(
≥
1/1,000 to
≤
1/100); rare (
≥
1/10,000 to
≤
1/1,000); very rare (
≤
1/10,000), not known (cannot be
estimated form the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4
Metabolism and nutrition disorder
Rare Loss of /or poor appetite
Very rare Dehydration
Nervous system disorders
Uncommon Headache
Rare Dizziness
Very rare Drowsiness, insomnia, fainting, reduced sense of taste
Respiratory, thoracic and mediastinal disorders
Rare
Respiratory symptoms (including rhinitis and cough)
Gastrointestinal disorders
Uncommon Diarrhoea, abdominal cramps, abdominal pain, stomach/abdominal gurgling (gas),
abdominal discomfort
Rare Vomiting, nausea
Very rare Sore throat, dyspepsia
Skin and subcutaneous tissue disorders
Very rare Sweating, rash
Musculoskeletal and connective tissue disorders
Very rare Joint pain
General disorders and administration site conditions
Rare Fever, malaise
Very rare Fatigue, shivers
Adverse reactions from post-marketing surveillance
Additional adverse reactions reported during post-marketing surveillance are listed below.
Infections and infestations: Gastroenteritis
Blood and lymphatic system disorders: Lymphadenitis
Nervous system disorders: Paraesthesia
Vascular disorders: Hypertension
Respiratory, thoracic and mediastinal disorders: Dyspnoea, increased sputum
Gastrointestinal disorders: Flatulence
Skin and subcutaneous tissue disorders: Urticaria, angioedema, pruritus
General disorders and administration site conditions: Pain, flu-syndrome, asthenia, chills
Data on overdose are extremely limited. Adverse reactions reported are consistent with those seen
after the recommended dosing.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Bacterial vaccines, ATC-code:
J07AE01
Mechanism of action
5
The vaccine contains killed whole
V. cholerae
O1 bacteria and the recombinant non-toxic B-subunit of
the cholera toxin (CTB). Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and
Classical biotypes are included in the vaccine. DUKORAL is taken orally with bicarbonate buffer,
which protects the antigens from the gastric acid. The vaccine acts by inducing antibodies against both
the bacterial components and CTB. The antibacterial intestinal antibodies prevent the bacteria from
attaching to the intestinal wall thereby impeding colonisation of
V. cholerae
O1. The anti-toxin
intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby
preventing the toxin-mediated diarrhoeal symptoms.
The heat-labile toxin (LT) of enterotoxigenic
E. coli
(ETEC ) is structurally, functionally and
immunologically similar to CTB. The two toxins cross-react immunologically.
6
Efficacy against cholera
Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical
trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region). The number of
patients enrolled, dosage regimens and follow-up periods are shown in the following table.
Study
location
Year
Dosage regimen
Number
(Age groups)
Follow up
Cholera
Bangladesh 1985-88 3 doses at 6 week intervals
89,152
(2-65 years)
6 months-5 years
Peru,
military
1994
2 doses 7-11 days apart
1,563
(18-65 years)
5 months
Peru,
Pampas
1993-95 2 doses 2 weeks apart with a booster
dose 1 year later
21,924
(2-65 years)
2 years
In the Bangladesh field trial, protective efficacy of DUKORAL in the overall population was 85%
(95%CI: 56, 95, per-protocol analysis) for the initial 6 months of follow-up. Duration of vaccine
protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
Table: Protective efficacy against cholera in the Bangladesh
study (per-protocol analysis)
Protective efficacy, % (95% CI)
Adults and children >6
year
Children 2-6
years
6 months
76
(30, 92)
100
1
st
year
76
(60, 85)
44
(10, 65)
2
nd
year
60
(36, 76)
33
(-23, 64)
In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy
against cholera after 2 vaccine doses was 85% (95%CI: 36, 97, per-protocol analysis). The third study,
a field trial conducted in Peru, failed to show any protective efficacy against cholera during the first
year. Following a booster dose 10-12 months after primary immunisation, the protective efficacy
during the second year was 60.5% (95%CI: 28,79).
Protective efficacy of DUKORAL against cholera has not been studied following repeated booster
vaccination.
Immunogenicity
No established immunological correlates of protection against cholera after oral vaccination have been
identified. There is a poor correlation between serum antibody responses, including vibriocidal
antibody response, and protection. Locally produced secretory IgA antibodies in the intestine probably
mediate protective immunity.
The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects. Serum
vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects
and antitoxic antibodies in 78-87% of vaccinated subjects. A booster dose elicited an anamnestic
response indicative of an immune memory. The duration of the immunological memory was estimated
to last for at least 2 years in adults.
5.2 Pharmacokinetic properties
Not applicable.
7
5.3 Preclinical safety data
No preclinical safety testing with the vaccine has been conducted.
6.
6.1 List of excipients
Suspension:
Sodium dihydrogen phosphate monohydrate
Disodium hydrogen phosphate dihydrate
Sodium chloride
Water for injections
Effervescent granules:
Sodium hydrogen carbonate
Citric acid
Sodium carbonate, anhydrous
Saccharin sodium
Sodium citrate
Raspberry flavour
6.2 Incompatibilities
DUKORAL should only be mixed with the supplied effervescent granules dissolved in water. In the
absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
3 years.
After the effervescent granules have been dissolved in water and the vaccine suspension has been
added, the mixture should be drunk within 2 hours.
6.4 Special precautions for storage
Store in a refrigerator (2C – 8C).
Do not freeze.
6.5 Nature and contents of container
The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper
(bromobutyl rubber) and a screw cap.
The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of
polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.
Each dose of vaccine is supplied with one sachet of effervescent granules.
Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
8
The effervescent granules should be dissolved in approximately 150 ml of cool water. The vaccine vial
should be shaken and the vaccine suspension should then be added to the sodium hydrogen carbonate
solution and mixed well to obtain a colourless slightly opalescent solution.
Children 2 to 6 years of age:
half of the sodium hydrogen carbonate solution is poured away and the
remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Any unused product or waste material should be disposed of in accordance with local requirements.
7.
Crucell Sweden AB
S-105 21 Stockholm
Sweden
8.
EU/1/03/263/001-003
9.
Date of first authorisation: 28 April 2004
Date of latest renewal: 25 March 2009
MM/YYYY
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
.
9
ANNEX II
A.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE
SUBSTANCES AND MANUFACTURING
AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers of the biological active substances
Crucell Sweden AB
SE-105 21 Stockholm
Sweden
UniTech BioPharma AB
Storjorden 2
SE-864 31 Matfors
Sweden
Name and address of the manufacturer responsible for batch release
Crucell Sweden AB
SE-105 21 Stockholm
Sweden
B
CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
OTHER CONDITIONS
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the
official batch release will be undertaken by a state laboratory or a laboratory designated for that
purpose
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
DUKORAL – 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve)
1.
DUKORAL suspension and effervescent granules for oral suspension
Cholera vaccine (inactivated, oral)
2.
STATEMENT OF ACTIVE SUBSTANCES
Active substances: 1 dose contains
25x10
9
bacteria* of each of the following
V. cholerae
O1 strains: Inaba classical biotype (heat
inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat
inactivated), Ogawa classical biotype (formalin inactivated).
Recombinant cholera toxin B subunit (rCTB) 1 mg.
*bacterial content prior to inactivation
3.
LIST OF EXCIPIENTS
Contains sodium. See the package leaflet for further information.
4.
3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
1 dose
2x1 dose
20x1 dose
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Instructions
1. Dissolve the effervescent granules in a glass of cool water (approx. 150 ml).
Children 2-6 years: pour away half of the solution.
2. Shake the vaccine vial (1 vial = 1 dose).
3. Add the vaccine to the sodium hydrogen carbonate solution. Mix well and drink the mixture.
For oral use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
14
8.
EXPIRY DATE
EXP MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Crucell Sweden AB
105 21 Stockholm, Sweden
EU/1/03/263/001 1 dose
EU/1/03/263/002 2x1 dose
EU/1/03/263/003 20x1 dose
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
DUKORAL
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
DUKORAL – 20x1 dose package (inner carton for 20 vaccine vials)
1.
DUKORAL suspension
Cholera vaccine (inactivated, oral)
2.
STATEMENT OF ACTIVE SUBSTANCES
Active substances: 1 dose contains
25x10
9
bacteria* of each of the following
V. cholerae
O1 strains: Inaba classical biotype (heat
inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat
inactivated), Ogawa classical biotype (formalin inactivated).
Recombinant cholera toxin B subunit (rCTB) 1 mg.
*bacterial content prior to inactivation
3.
LIST OF EXCIPIENTS
Contains sodium. See the package leaflet for further information.
4.
3 ml of suspension in a vial.
20x1 dose
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP MM/YYYY
16
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Crucell Sweden AB
105 21 Stockholm, Sweden
EU/1/03/263/003
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
17
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
DUKORAL – 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
1.
Sodium hydrogen carbonate
Effervescent granules
2.
STATEMENT OF ACTIVE SUBSTANCES
3.
LIST OF EXCIPIENTS
Contains sodium. See the package leaflet for further information.
4.
20 x 5.6 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
To be used with DUKORAL.
For oral use.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
18
Crucell Sweden AB
105 21 Stockholm, Sweden
EU/1/03/263/003
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
DUKORAL, vial label 1 dose
1.
DUKORAL suspension
Oral use.
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use.
3.
EXPIRY DATE
EXP MM/YYYY
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1 dose (3 ml)
6.
OTHER
20
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Sodium hydrogen carbonate 5.6 g, sachet
1.
Sodium hydrogen carbonate effervescent granules
Oral use.
2.
METHOD OF ADMINISTRATION
To be used with DUKORAL.
Read the package leaflet before use.
3.
EXPIRY DATE
EXP MM/YYYY
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5.6 g
6.
OTHER
Crucell Sweden AB, Sweden
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUKORAL suspension and effervescent granules for oral suspension
Cholera vaccine (inactivated, oral)
Read all of this leaflet carefully before you start using this vaccine.
-
Keep this leaflet. You may need to read it again.
-
This vaccine has been prescribed for you. Do not pass it on to others.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What DUKORAL is and what it is used for
2.
Before you use DUKORAL
3.
How to use DUKORAL
5
How to store DUKORAL
6.
Further information
1.
WHAT DUKORAL IS AND WHAT IT IS USED FOR
DUKORAL is an oral vaccine against cholera that stimulates the immunological defence in the gut.
The vaccine protects adults and children from 2 years of age against cholera.
2.
BEFORE YOU USE DUKORAL
Do not use DUKORAL
-
if you are allergic to any ingredient of the vaccine or to formaldehyde.
-
if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
Take special care with DUKORAL
-
Tell your doctor if you take a medical treatment that affects the immune system or if you have a
disease of the immune system (including AIDS). The vaccine may provide you with a lower level of
protection than it does for people with healthy immune systems.
The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene
advice to avoid diarrhoeal diseases.
Using other medicines
Do not take other medicine 1 hour before and 1 hour after taking the vaccine. Please tell your doctor or
pharmacist if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
Using DUKORAL with food and drink
Avoid food and drink 1 hour before and 1 hour after the vaccination.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant or are
breast-feeding. Your doctor will decide if you should receive the vaccine DUKORAL’
Driving and using machines
There are no reasons to suspect that DUKORAL will affect your ability to drive or handle machines
23
-
If you have any further questions, ask your doctor or pharmacist.
4.
Possible side effects
Important information about some of the ingredients of DUKORAL
DUKORAL contains approximately 1.1 g sodium per dose. To be taken into consideration by patients
on a controlled sodium diet.
3. HOW TO USE DUKORAL
Adults and children from 6 years of age:
The primary vaccination is 2 doses. Doses are to be taken
with an interval of 1 to 6 weeks. For continuous protection, re-vaccination is recommended after 2
years. If up to 2 years have passed since the last vaccination a single dose is sufficient. If more than 2
years have passed since the last vaccination, the primary vaccination (2 doses) should be repeated.
Children of 2 to 6 years of age:
The primary vaccination is 3 doses. Only half of the amount of the
sodium hydrogen carbonate solution should be mixed with the vaccine. Doses are to be taken with an
interval of 1 to 6 weeks. For continuous protection, re-vaccination is recommended after 6 months. If
up to 2 years have passed since the last vaccination a single dose is sufficient. If more than 2 years
have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Protection against cholera can be expected about 1 week after the primary vaccination is completed.
The vaccine is a whitish suspension supplied in a single-dose glass vial. Each dose of vaccine comes
with one sachet package that contains white effervescent granules of sodium hydrogen carbonate. The
granules should be dissolved in a glass of water and mixed with the vaccine. The sodium hydrogen
carbonate solution protects the vaccine from the gastric acid.
Drink the vaccine within 2 hours after mixing with the sodium hydrogen carbonate solution.
Instructions:
1. Dissolve the effervescent granules (sodium hydrogen carbonate) in a glass of
cool water (approx. 150 ml).
Children 2-6 years: pour away half of the solution.
2. Shake the vaccine vial (1 vial = 1 dose).
3. Add the vaccine to the sodium hydrogen carbonate solution. Mix well and
drink the mixture.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, DUKORAL can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
24
Uncommon side effects (reported by less than 1 in a 100 but more than 1 in a 1,000 people) include:
diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and
general stomach discomfort, headache
Rare side effects (reported by less than 1 in a 1,000 but more than 1 in a 10,000 people) include:
high temperature, generally feeling unwell, nausea, vomiting, loss of /or poor appetite, runny nose,
cough and dizziness.
Very rare side effects (reported by less than 1 in a 10,000 people) include: fatigue/feeling tired,
shivering, severe diarrhoea, joint pain, sore throat, reduced sense of taste, sweating, being unable to
sleep, general pain, hives or nettle rash, other types of rashes, flu-like symptoms, weakness, feeling
cold, breathlessness, pins and needles, dehydration (loss of water from the body), swelling of face,
high blood pressure, chestiness, itching, and swelling of the lymph glands.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE DUKORAL
Keep out of the reach and sight of children.
Do not use DUKORAL after the expiry date which is stated on the carton.
Store in a refrigerator (2C – 8C). Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What DUKORAL contains
-
The active substances are:
25x10
9
bacteria* of each of the following
V. cholerae
O1 strains: Inaba classical biotype (heat
inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat
inactivated), Ogawa classical biotype (formalin inactivated).
Recombinant cholera toxin B subunit (rCTB) 1 mg.
*bacterial content prior to inactivation
-
The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium
hydrogen phosphate, sodium chloride and water for injections.
-
The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate,
saccharin sodium, sodium citrate and raspberry flavour.
What DUKORAL looks like and contents of the pack
DUKORAL is presented as a suspension and effervescent granules for oral suspension. The vaccine is
a whitish suspension supplied in a vial. The sodium hydrogen carbonate is white effervescent granules
with a raspberry flavour supplied in a sachet.
DUKORAL is available in packs of 1, 2 and 20 doses. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crucell Sweden AB, 105 21 Stockholm, Sweden.
This leaflet was last approved in
MM/YYYY
25
Source: European Medicines Agency
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